MANUFACTURING FACILITY
State-of-the-art production facilities ensuring top-quality excipients
Mahape (Navi Mumbai)
Our state-of-the-art manufacturing unit, located in Navi Mumbai, spans 1500 sq. m. and adheres to WHO cGMP guidelines. The facility is equipped with modern infrastructure, advanced equipment, and dedicated departments for formulation, quality assurance, quality control, warehousing, and production. With a production capacity of 720 MT per annum and plans for expansion to 1080 MT per annum, the unit is staffed by a skilled workforce of approximately 125 employees.
Infrastructure & Equipment
- Dedicated areas for production, packaging, and quality control
- Advanced warehouse with separate sections for raw materials and packing
- Stability chambers for real-time and accelerated testing
- Cutting-edge coating facilities with multiple autocoaters
- Comprehensive HVAC and water purification systems ensuring controlled environments
Our Commitment to Quality
- Regularly audited by Indian and international regulatory organizations
- Sourcing raw materials from certified pharmaceutical-grade vendors
- Ensure strict quality control throughout the production process.
Key Features
Quality Assurance Department - Well trained and qualified team
- Quality Management Systems (QMS)
- Validations and Qualifications
- Training programs
Quality Control Department - Ensures raw materials and finished products meet industry standards.
- Wet Laboratory
- Instrument Laboratory
- Microbiology Laboratory
- Equipped with the advanced Colour Matching Spectrophotometer for accurate testing
Regulatory Assistance - Compliance with international regulatory guidelines
Novo Excipients provides full regulatory assistance to support US DMF, CHINA DMF and EU compliance, offering documents such as:
- GMP and HALAL certificates
- ISO 9001:2008 certification
- Acute Oral Toxicity Study Data
- Stability Study Data
- Non-GMO, TSE/BSE, and Allergen-Free Statements
- GRAS ingredient statements
- Material Safety Data Sheet (MSDS)
- And many more…
Upon customer request, we provide our pharmaceutical specialty excipients with certificates detailing potential risks related to Nitrosamine and elemental impurities, in full compliance with regulatory standards.
Our Novoseries products are free from Nitrosamine impurities.
